Expectancy, Self-Efficacy, and Placebo Effect of a Sham Supplement for Weight Loss in Obese Adults.

This study examined the role of expectancy in the placebo effect of a sham dietary supplement for weight loss in 114 obese adults with metabolic syndrome. All participants received lifestyle education and were randomized to 1 of 3 conditions: (1) a daily placebo capsule and told that they were taking an active weight loss supplement, (2) daily placebo and told they had a 50% random chance of receiving either the active or placebo, or (3) no capsules. At 12 weeks, weight loss and metabolic outcomes were similar among the 3 groups. Participants in both groups that took capsules showed decreased weight loss self-efficacy and increased expectations of benefit from dietary supplements. Participants not taking capsules showed the opposite. Adverse events were more frequently reported in groups taking capsules than those who were not. These findings suggest that supplements without weight loss effects may have nocebo effects through diminished self-efficacy.

Static magnetic field therapy for carpal tunnel syndrome: a feasibility study.

OBJECTIVES: To assess the feasibility of conducting trials of static magnetic field (SMF) therapy for carpal tunnel syndrome (CTS), to collect preliminary data on the effectiveness of 2 SMF dosages, and to explore the influence of an SMF on median nerve conduction. DESIGN: Randomized, double-blind, sham-controlled trial with a 6-week intervention and a 12-week follow-up. SETTING: University hospital outpatient clinics. PARTICIPANTS: Women and men (N=60), ages 21 to 65 years, with an electrophysiologically confirmed CTS diagnosis recruited from the general population. INTERVENTIONS: Participants wore nightly either neodymium magnets that delivered either 15 or 45 mTesla (mT) to the contents of the carpal canal or a nonmagnetic disk. MAIN OUTCOME MEASURES: Symptom Severity Scale (SSS) and Function Severity Scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) and 4 median nerve parameters: sensory distal latency, sensory nerve action potential amplitude, motor distal latency and compound motor action potential amplitude. RESULTS: Fifty-eight of 60 randomized participants completed the study. There were no significant between-group differences for change in the primary endpoint SSS or for FSS or median nerve conduction parameters. For the SSS and the FSS, each group showed a reduction at 6 weeks indicating improvement in symptoms. CONCLUSIONS: This study showed the feasibility and safety of testing SMF therapy for CTS. There were no between-group differences observed for the BCTQ or median nerve parameters after 6 weeks of SMF therapy. Significant within-group, symptomatic improvements of the same magnitude were experienced by participants in both active and sham magnet groups. Future studies are needed to optimize SMF dosimetry and resolve issues related to the use of sham controls in SMF trials.

In vivo effects of Ashwagandha (Withania somnifera) extract on the activation of lymphocytes.

OBJECTIVE: This study investigated the immunologic effects of Ashwagandha (Withania somnifera) on four types of immune cells in a human sample to determine the immunologic mechanism. DESIGN: Five (5) participants consumed 6 mL of an Ashwagandha root extract twice daily for 96 hours. Ashwagandha was administered with anupana (whole milk). Peripheral blood samples were collected at 0, 24, and 96 hours and compared for differences in cell surface expression of CD4, CD8, CD19, CD56, and CD69 receptors by flow cytometry. RESULTS: Significant increases were observed in the expression of CD4 on CD3+ T cells after 96 hours. CD56+ NK cells were also activated after 96 hours as evidenced by expression of the CD69 receptor. At 96 hours of use, mean values of receptor expression for all measured receptor types were increased over baseline, indicating that a major change in immune cell activation occurred across the sample. CONCLUSIONS: Effects on immune cell activation with use of Ashwagandha warrant further study.

Hippocampal zinc infusion delays the development of afterdischarges and seizures in a kindling model of epilepsy.

PURPOSE: Zinc occurs in high concentration in synaptic vesicles of glutamatergic terminals including hippocampal mossy fibers. This vesicular zinc can be synaptically released during neuronal activity, including seizures. Zinc inhibits certain subtypes of N-methyl-D-aspartate (NMDA) and gamma-aminobutyric acid (GABA)(A) receptors. By blocking NMDA excitation or GABA inhibition, an excess of zinc may alter the excitability of hippocampal circuits, which contribute to the development of seizures. METHODS: Twenty-one adult Wistar rats were implanted under anesthesia with Alzet pumps releasing vehicle, 10 microM ZnCl(2) or 1,000 microM ZnCl(2), at a rate of 0.25 microl/h continuously into the hippocampal hilus for 4 weeks. Kindling was performed by daily awake commissural stimulation at 60 Hz and afterdischarges were recorded from a dentate gyrus electrode. Development of behavioral Racine seizure stages was recorded by a blinded investigator. RESULTS: The development of behavioral Racine seizure stages was delayed only in rats infused with 1,000 microM ZnCl(2) (p < 0.02). With completion of kindling at stimulation number 20, all groups had reached the same maximum level of behavioral seizures. The expected increased progression of afterdischarge duration was inhibited by both 10 microM ZnCl(2) and 1,000 microM ZnCl(2) infusion compared to control animals (p < 0.01). At stimulation number 18, all groups had reached the same maximum duration of afterdischarges. DISCUSSION: We conclude that excess infused zinc delayed the development of behavioral seizures in a kindling model of epilepsy. These data support the hypothesis that zinc synaptically released during seizures may alter hippocampal excitability similar to zinc infused in our experiment.

Static magnetic field therapy: a critical review of treatment parameters.

Static magnetic field (SMF) therapy, applied via a permanent magnet attached to the skin, is used by people worldwide for self-care. Despite a lack of established SMF dosage and treatment regimens, multiple studies are conducted to evaluate SMF therapy effectiveness. Our objectives in conducting this review are to:(i) summarize SMF research conducted in humans; (ii) critically evaluate reporting quality of SMF dosages and treatment parameters and (iii) propose a set of criteria for reporting SMF treatment parameters in future clinical trials. We searched 27 electronic databases and reference lists. Only English language human studies were included. Excluded were studies of electromagnetic fields, transcranial magnetic stimulation, magnets placed on acupuncture points, animal studies, abstracts, posters and editorials. Data were extracted on clinical indication, study design and 10 essential SMF parameters. Three reviewers assessed quality of reporting and calculated a quality assessment score for each of the 10 treatment parameters. Fifty-six studies were reviewed, 42 conducted in patient populations and 14 in healthy volunteers. The SMF treatment parameters most often and most completely described were site of application, magnet support device and frequency and duration of application. Least often and least completely described were characteristics of the SMF: magnet dimensions, measured field strength and estimated distance of the magnet from the target tissue. Thirty-four (61%) of studies failed to provide enough detail about SMF dosage to permit protocol replication by other investigators. Our findings highlight the need to optimize SMF dosing parameters for individual clinical conditions before proceeding to a full-scale clinical trial.

A liquid chromatography/tandem mass spectrometry method for determination of 25-hydroxy vitamin D2 and 25-hydroxy vitamin D3 in dried blood spots: a potential adjunct to diabetes and cardiometabolic risk screening.

BACKGROUND: Now emerging as an important risk factor for type 1 diabetes, vitamin D deficiency is also associated with obesity, metabolic syndrome, and type 2 diabetes and has been identified as a potential cardiometabolic risk factor. A simple, accurate screening test for 25-hydroxy vitamin D [25(OH)D] deficiency is needed. We developed a liquid chromatography/tandem mass spectrometry assay for 25-hydroxy vitamin D(2) [25(OH)D(2)] and 25-hydroxy vitamin D(3) [25(OH)D(3)] in dried blood spots. METHOD: Blood spots were collected by finger stick simultaneously with serum samples obtained by venipuncture from healthy volunteers. Disks punched from the dried blood spots were sonicated with an internal standard solution of deuterated 25(OH)D(3) (26,26,26,27,27,27-d(6)). Methanol was added to precipitate proteins prior to extraction with hexane. The extracted samples were dried and reconstituted in 50:50 methanol:H(2)O before injection into a Varian 320-MS TQ mass spectrometer. RESULTS: BLOOD SPOT ASSAY PRECISION WAS GOOD OVER THE REPORTABLE RANGE: interassay coefficients of variation were 13, 13, and 11% at concentrations of 14, 26, and 81 ng/ml, respectively, for 25-hydroxy vitamin D(3) and 12% at 23 ng/ml for 25(OH)D(2). The 25(OH)D(3) assay was linear from 3.5 to 75 ng/ml (R > 0.99). Blood spot and serum values showed excellent correlation for 25(OH)D(2) (R=0.90, n=54) and 25(OH)D(3) (R=0.91, n=83). CONCLUSIONS: This blood spot assay for 25(OH)D(2) and 25(OH)D(3) provides a convenient and cost-effective alternative to serum assays and can be automated. This may be valuable in large-scale screening for risk of type 1 diabetes, for cardiometabolic risk screening, and for monitoring vitamin D supplementation.

A multichannel system for continuous measurements of skin resistance and capacitance at acupuncture points.

Electrodermal screening (EDS) is based on three commonly held assumptions: acupuncture points (APs) have lower electrical resistance than non-APs; resistance at APs varies with health and disease; and effective acupuncture treatments are associated with normalization of resistance at APs. Although evidence confirming these assumptions is limited, EDS is frequently practiced worldwide. Researchers are also beginning to assess EDS' utility as an outcome measure in acupuncture trials. Fundamental in developing EDS as a research tool is the need for an accurate and reliable measurement. We developed an automated multichannel prototype system, the Octopus, and recorded electrical resistance and capacitance at eight skin sites in 33 healthy participants over 2 hours. The Octopus accurately measured against known resistors (within 2.5% of the mean value) and capacitors (within 10% of the mean value), and yielded repeatable readings at all eight skin sites: LR 1 (r=0.79), SP 1 (r=0.79), toe non-AP (r=0.77), LU 9 (r=0.97), PC 6 (r=0.96), wrist non-APs (r=0.97), SP 6 (r=0.96), and leg non-APs (r=0.97). Resistance at APs was significantly lower than the nearby non-APs in one out of three comparisons.

Skin impedance measurements for acupuncture research: development of a continuous recording system.

Skin impedance at acupuncture points (APs) has been used as a diagnostic/therapeutic aid for more than 50 years. Currently, researchers are evaluating the electrophysiologic properties of APs as a possible means of understanding acupuncture's mechanism. To comprehensively assess the diagnostic, therapeutic and mechanistic implications of acupuncture point skin impedance, a device capable of reliably recording impedances from 100 kOmega to 50 MOmega at multiple APs over extended time periods is needed. This article describes design considerations, development and testing of a single channel skin impedance system (hardware, control software and customized electrodes). The system was tested for accuracy against known resistors and capacitors. Two electrodes (the AMI and the ORI) were compared for reliability of recording over 30 min. Two APs (LU 9 and PC 6) and a nearby non-AP site were measured simultaneously in four individuals for 60 min. Our measurement system performed accurately (within 5%) against known resistors (580 kOmega-10 MOmega) and capacitors (10 nF-150 nF). Both the AMI electrode and the modified ORI electrode recorded skin impedance reliably on the volar surface of the forearm (r = 0.87 and r = 0.79, respectively). In four of four volunteers tested, skin impedance at LU 9 was less than at the nearby non-AP site. In three of four volunteers skin impedance was less at PC 6 than at the nearby non-AP site. We conclude that our system is a suitable device upon which we can develop a fully automated multi-channel device capable of recording skin impedance at multiple APs simultaneously over 24 h.

Effects of a standardized Bacopa monnieri extract on cognitive performance, anxiety, and depression in the elderly: a randomized, double-blind, placebo-controlled trial.

OBJECTIVES: Study aims were to evaluate effects of Bacopa monnieri whole plant standardized dry extract on cognitive function and affect and its safety and tolerability in healthy elderly study participants. DESIGN: The study was a randomized, double-blind, placebo-controlled clinical trial with a placebo run-in of 6 weeks and a treatment period of 12 weeks. SETTING/LOCATION: Volunteers were recruited from the community to a clinic in Portland, Oregon by public notification. SUBJECTS: Fifty-four (54) participants, 65 or older (mean 73.5 years), without clinical signs of dementia, were recruited and randomized to Bacopa or placebo. Forty-eight (48) completed the study with 24 in each group. INTERVENTIONS: Standardized B. monnieri extract 300 mg/day or a similar placebo tablet orally for 12 weeks. OUTCOME MEASURES: The primary outcome variable was the delayed recall score from the Rey Auditory Verbal Learning Test (AVLT). Other cognitive measures were the Stroop Task assessing the ability to ignore irrelevant information, the Divided Attention Task (DAT), and the Wechsler Adult Intelligence Scale (WAIS) letter-digit test of immediate working memory. Affective measures were the State-Trait Anxiety Inventory, Center for Epidemiologic Studies Depression scale (CESD)-10 depression scale, and the Profile of Mood States. Vital signs were also monitored. RESULTS: Controlling for baseline cognitive deficit using the Blessed Orientation-Memory-Concentration test, Bacopa participants had enhanced AVLT delayed word recall memory scores relative to placebo. Stroop results were similarly significant, with the Bacopa group improving and the placebo group unchanged. CESD-10 depression scores, combined state plus trait anxiety scores, and heart rate decreased over time for the Bacopa group but increased for the placebo group. No effects were found on the DAT, WAIS digit task, mood, or blood pressure. The dose was well tolerated with few adverse events (Bacopa n = 9, placebo n = 10), primarily stomach upset. CONCLUSIONS: This study provides further evidence that B. monnieri has potential for safely enhancing cognitive performance in the aging.

Treatment of experimental autoimmune encephalomyelitis with alpha lipoic acid and associative conditioning.

We have initiated studies to evaluate the suitability of performing therapeutic conditioning trials in experimental autoimmune encephalomyelitis (EAE) mice treated with alpha lipoic acid (ALA). EAE was induced in SJL mice by active immunization with myelin antigen. Once daily subcutaneous injection of ALA served as the unconditional stimulus (US) administered with the conditional stimulus (CS) saccharin-flavored drinking water under a regimen of restricted water access. In the first study, we found that water restriction and saccharin administration were compatible with disease development and effective ALA treatment of EAE mice. In the second study, mice were conditioned to once daily administration of ALA paired with administration of saccharin-flavored water (US+CS) on days 7-16. Test trials spanned experimental days 17-32 in groups receiving either saccharin-flavored water (CS, in the experimental group) versus unflavored water (CSo, in the control group) and compared several measures of EAE severity using multivariate ANOVA (MANOVA). Reduced disease severity in the experimental group (US+CS:CS) compared to the control group (US+CS:CSo) suggested that conditioning had occurred. These results demonstrate an approach for conducting therapeutic conditioning trials in EAE mice and suggest considerations for future investigations.

Discriminators of Complementary and Alternative Medicine provider use among men with HIV/AIDS.

OBJECTIVE: To examine comprehensively the potential correlates of Complementary and Alternative Medicine (CAM) practitioner use among men with HIV/AIDS. METHODS: Men (n=122) recruited from HIV/AIDS service organizations completed extensive written surveys. Questions comprised several domains that have been thought or demonstrated to influence individuals to use CAM, and also addressed respondents' social networks. RESULTS: Discriminant analyses revealed 2 social network variables and 2 attitudinal variables proved statistically significant when controlling for relationships among variables. CONCLUSION: The significant contribution of social influence/social networks in choosing CAM modalities demonstrated has not heretofore been examined in CAM user studies; implications for future research are discussed.

The effect of Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra on CD25 expression in humans: a pilot study.

This phase 0, double-blind, repeated within subject, randomized pilot study examined CD25 expression on T cells after ingestion of three commonly used herbs: Echinacea purpurea, Astragalus membranaceus and Glycyrrhiza glabra, administered singly and in combination. CD25 expression on T cells was significantly increased for subjects ingesting Echinacea at 24 h with notable increases in activation from Astragalus and Glycyrrhiza. CD25 expression remains elevated with daily use of Echinacea for at least 7 days.